MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO MINI BYPASS GRAFT; EPTFE VASCULAR GRAFT

Catalog Number DFX8006SC

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2016

Event Type  malfunction  

Manufacturer Narrative

No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore in the femoral artery; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual inspection: the one segment had two blue lines running down the length of the graft and carbon inner lining, thus identifying it as a bard product.Trace amounts of fluid were visible along the body of the graft segment.The segment measured approximately 1.9cm in length.No suture holes were identified.The beading was peeled off throughout the entire length of the segment.The segment was torn spirally in two location along the beading track.One end of the segment appears torn while the other end appears to be cut.Dimensional evaluation: segment of the graft measured approximately 1.9 cm in total length.This measurement was below specification.Therefore, the entirety of the graft was not returned for evaluation.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation was confirmed for torn material, as partial circumferential tears were observed along the beading track of the returned segment.The definitive root cause could not be determined based upon available information.It was unknown whether patient and/or procedural issues contributed to the event.Further investigation is being performed to determined the bead tear issue across eptfe vascular graft products.Labeling review: the current ifu states: precautions: when removing the external spiral support (beading) of the distaflo® graft, the beading must be removed slowly and at a 90° angle to the graft.Rapid unwinding and /or removal at less than a 90° angle may result in graft damage.Do not use surgical blades or sharp, pointed instruments to remove the beading as this may damage the graft wall.If damage occurs, that segment of the graft should not be used.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during an intraoperative procedure, upon removal of the beading from the vascular graft, the graft allegedly tore in the femoral artery; therefore, the graft was shortened and the anastomosis was completed with the remainder of the graft.There was no reported patient injury.

• Brand Name: DISTAFLO MINI BYPASS GRAFT
• Type of Device: EPTFE VASCULAR GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6187549
• MDR Text Key: 62789770
• Report Number: 2020394-2016-01181
• Device Sequence Number: 1
• Product Code: DYF
• UDI-Device Identifier: 00801741023675
• UDI-Public: (01)00801741023675(17)201202(10)VTZL0099
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K983769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: DFX8006SC
• Device Lot Number: VTZL0099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1